FDA Medical Approval in the United States
In the United States (US), the role of the Food and Drug Administration (FDA) is to protect public health by allowing only safe and effective products to enter the market, and by monitoring products for continued safety after they are in use. The FDA is responsible for regulating companies that manufacture or import Medical Devices sold in the US.
FDA Medical Device Strategy
Medical devices are classified into three classes by the FDA: Class I being the lowest risk and Class III the highest risk. (details on classification 21 CFR, parts 800-1107).
The low-risk medical devices, are known as "Class I" and are exempt from FDA review. Medium risk devices require 510(k) Pre-market Notification to be sold in the US, while high-risk devices must go through the Premarket Approval (PMA) application under section 515 of the FD&C Act in order to obtain market access.
Classification for FDA Medical Devices
The US FDA uses a predicate-based system to classify medical devices as Class I, II or III based on the increased risk to the patient or user.
To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device. There are 2 methods to find this:
- The classification database and search for a part of the device name
- Device panel to which your device belongs
For each of the devices classified by the FDA, the CFR gives a general description including the intended use, the class to which the device belongs and information about the marketing requirements. Your device should meet the definition in a classification regulation contained in 21 CFR – 862-892.
Market Access in the Unites States
After the device classification, you then select the premarket submission required for that regulation.
All routes to US Market Access
US FDA Agent
All medical devices have to be listed with the FDA (Medical Device Listing) and all companies intending to market their medical devices in the US must notify the FDA of their intention and be registered (Establishment Registration), prior to the introduction of their products into the US market. Regardless of the product classification, Quality Systems Regulations (QSR) compliance is almost always required. Manufacturers located outside of the United States are required to appoint a US FDA Agent to serve as their intermediary with the FDA.